MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-04 for VARADY PHLEBOEXTRACTOR 09.95.92 manufactured by Medicon E.g..
[145769928]
The device was returned without the broken-off tip. Magnified visual inspection of the device showed that it had been bent several times. This does not conform to best practices for the device, which is not intended to be bent. The fractured surface revealed a structure typical of forceful breakage, indicating application of undue force as the most probable cause of this event. [(b)(4)].
Patient Sequence No: 1, Text Type: N, H10
[145769929]
The device tip broke off during clinical use and was immediately removed from the operative field. There were no consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010099-2019-00005 |
| MDR Report Key | 8580692 |
| Date Received | 2019-05-04 |
| Date of Report | 2019-05-04 |
| Date of Event | 2017-04-05 |
| Date Mfgr Received | 2017-04-12 |
| Device Manufacturer Date | 2014-06-03 |
| Date Added to Maude | 2019-05-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANTON MITTERMUELLER |
| Manufacturer Street | GAENSAECKER 15 |
| Manufacturer City | TUTTLINGEN, 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78532 |
| Manufacturer G1 | MEDICON E.G. |
| Manufacturer Street | GAENSAECKER 15 |
| Manufacturer City | TUTTLINGEN, 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VARADY PHLEBOEXTRACTOR |
| Generic Name | PHLEBOEXTRACTOR |
| Product Code | GDI |
| Date Received | 2019-05-04 |
| Catalog Number | 09.95.92 |
| Lot Number | 753W |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICON E.G. |
| Manufacturer Address | GAENSAECKER 15 TUTTLINGEN, 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-04 |